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Journal of Pharmaceutical Research

Article

Journal of Pharmaceutical Research

Year: 2023, Volume: 22, Issue: 1, Pages: 27-36

Original Article

Fabrication of Sublingual Alprazolam Wafers using Mucoadhesive Vigna mungo L. Seeds and Characterized with Texture Analyzer QTS-25

Abstract

Our primary goal of this work was to create and test a mucoadhesive lyophilized rapid dissolving sublingual wafer of Alprazolam using a natural mucoadhesive agent extracted from black gram (Vigna mungo L.) seeds. We examined the pH, swelling volume, moisture absorption capability, mucoadhesive strength, and viscosity of the natural mucoadhesive agent. We compared it with synthetic mucoadhesive agents such as Hydroxypropyl cellulose (HPC) and Carbopol 934 (CP 934). The prepared wafers of both categories were characterized and compared for mechanical and texture properties, wetting time, disintegration time, Scanning Electron Microscopy (SEM), in vitro drug release, and ex vivo permeation study. We found that the pH of V. mungo mucilage (VMM) was 6.95±0.75, which lies between the normal sublingual mucosal range (pH 6-7), suggesting non-irritability to the mucosa. Attenuated total reflectance-Fourier-transform infrared (ATR-FTIR) peak showed no significant interaction between Alprazolam and mucoadhesive materials. The micrographs of SEM predicted good porosity of the wafer which leads to rapid wetting, disintegration, and dissolution. It is inferred from the study that the fast-dissolving wafer prepared from the VMM gave a better result than the HPC wafer in respect of various parameters. Hence, this study discovered an alternative method to deliver Alprazolam.

Keywords: Lyophilization, Permeability, Solid dosage form(s), Mucoadhesive, Texture

References

  1. Ali S, Ahmad S, Alam S, Alam N, Alam I. Trend in Fast Dissolving Tablets: An Overview. Research Journal of Pharmacy and Technology. 2016;9(1):69–78. Available from: http://dx.doi.org/10.5958/0974-360X.2016.00012.3
  2. Hannan PA, Khan JA, Khan A, Safiullah S. Oral Dispersible System: A New Approach in Drug Delivery System. Indian J Pharm Sci. 2016;78(1):2–7. Available from: https://doi.org/10.4103/0250-474x.180244
  3. Singh A, Kharb V, Saharan VA. Fast Dissolving/Disintegrating Dosage Forms of Natural Active Compounds and Alternative Medicines. Recent Pat Drug Deliv Formul . 2020;14:21–39. Available from: https://doi.org/10.2174/187221131466620032417470
  4. Rahane RD, Rachh PR. A Review on Fast Dissolving Tablet. Journal of Drug Delivery and Therapeutics. 2018;8(5):50–55. Available from: https://doi.org/10.22270/jddt.v8i5.1888
  5. Patoliya N, Joshi B, Upadhyay U. Future Prospect of Oral Disintegration drug Delivery system: A Review. Res. J. Pharma. Dosage Forms and Tech. 2021;13(1):66–71. Available from: https://doi.org/10.5958/0975-4377.2021.00012.4
  6. Ait-Daoud N, Hamby AS, Sharma S, Blevins D. A Review of Alprazolam Use, Misuse, and Withdrawal. J Addict Med. 2018;12(1):4–10. Available from: https://doi.org/10.1097/ADM.0000000000000350
  7. Koirala S, Nepal P, Ghimire G, Basnet R, Rawat I, Dahal A, et al. Formulation and evaluation of mucoadhesive buccal tablets of aceclofenac. Heliyon. 2021;7(3):e06439. Available from: https://doi.org/10.1016/j.heliyon.2021.e06439
  8. Matthews KH, Stevens HN, Auffret AD, Humphrey MJ, Eccleston GM. Lyophilised wafers as a drug delivery system for wound healing containing methylcellulose as a viscosity modifier. Int J Pharm. 2004;289(1-2):51–62. Available from: https://doi.org/10.1016/j.ijpharm.2004.10.022
  9. Boateng JS, Auffret AD, Matthews KH, Humphrey MJ, Stevens HN, Eccleston GM. Characterisation of freeze-dried wafers and solvent evaporated films as potential drug delivery systems to mucosal surfaces. Int J Pharm. 2010;389(1-2):24–31. Available from: https://doi.org/10.1016/j.ijpharm.2010.01.008
  10. Zepon ΚM, Marques MS, Hansen AW, Pucci CDAF, Morisso FDP, Ziulkoski AL, et al. Polymer-based wafers containing in situ synthesized gold nanoparticles as a potential wound-dressing material. Materials Science and Engineering: C. 2020;109(110630). Available from: https://doi.org/10.1016/j.msec.2020.110630
  11. Boateng J, Burgos-Amador R, Okeke O, Pawar H. Composite alginate and gelatin based bio-polymeric wafers containing silver sulfadiazine for wound healing. Int J BiolMacromol. 2015;79:63–71. Available from: https://doi.org/10.1016/j.ijbiomac.2015.04.048
  12. Patel R, Pillay V, Choonara YE, Govender T. A Novel Cellulose-Based Hydrophilic Wafer Matrix for Rapid Bioactive Delivery. Journal of Bioactive and Compatible Polymers. 2007;22(2):119–142. Available from: https://doi.org/10.1177/0883911506076045
  13. Abdelkader H, Fathalla Z, Seyfoddin A, Farahani M, Thrimawithana T, Allahham A, et al. Polymeric long-acting drug delivery systems (LADDS) for treatment of chronic diseases: Inserts, patches, wafers, and implants. Adv Drug Deliv Rev. 2021;177:113957. Available from: https://doi.org/10.1016/j.addr.2021.113957
  14. Verma S, Tonk RK, Albratty M, Alhazmi HA, Najmi A, Kumar R, et al. Design and evaluation of sustained release mucoadhesive film of sumatriptan succinate containing grafted co-polymer as the platform. Saudi Pharmaceutical Journal. 2022;30(11):1527–1537. Available from: https://doi.org/10.1016/j.jsps.2022.07.014
  15. Xue J, Wu T, Dai Y, Xia Y. Methods, Materials, and Applications. Chem Rev. 2019;119(8):5298–5415. Available from: https://doi.org/10.1021/acs.chemrev.8b00593
  16. Nikam VK, Shete SK, Khapare JP. Most promising solid dispersion technique of oral dispersible tablet. Beni-Suef University Journal of Basic and Applied Sciences. 2020;9(1):1–6. Available from: https://doi.org/10.1186/s43088-020-00086-4
  17. Matthews KH, Stevens HN, Auffret AD, Humphrey MJ, Eccleston GM. Formulation, stability and thermal analysis of lyophilised wound healing wafers containing an insoluble MMP-3 inhibitor and a non-ionic surfactant. Int J Pharm. 2008;356(1-2):110–120. Available from: https://doi.org/10.1016/j.ijpharm.2007.12.043
  18. Sahatsapan N, Rojanarata T, Ngawhirunpat T, Opanasopit P, Tonglairoum P. 6-Maleimidohexanoic acid-grafted chitosan: A new generation mucoadhesive polymer. Carbohydrate Polymers. 2018;202:258–264. Available from: https://doi.org/10.1016/j.carbpol.2018.08.119
  19. Holder CF, Schaak RE. Tutorial on Powder X-ray Diffraction for Characterizing Nanoscale Materials. ACS Nano. 2019;13(7):7359–7365. Available from: https://doi.org/10.1021/acsnano.9b05157
  20. Alhayali A, Vuddanda PR, Velaga S. Silodosin oral films: Development, physico-mechanical properties and in vitro dissolution studies in simulated saliva. Journal of Drug Delivery Science and Technology. 2019;53:101122. Available from: https://doi.org/10.1016/j.jddst.2019.06.019
  21. Pacheco MS, Barbieri D, Silva CFD, Moraes MAD. A review on orally disintegrating films (ODFs) made from natural polymers such as pullulan, maltodextrin, starch, and others. Int J BiolMacromol. 2021;178:504–513. Available from: https://doi.org/10.1016/j.ijbiomac.2021.02.180
  22. Pham QD, Nöjd S, Edman M, Lindell K, Topgaard D, Wahlgren M. Mucoadhesion: mucin-polymer molecular interactions. International Journal of Pharmaceutics. 2021;610(121245). Available from: https://doi.org/10.1016/j.ijpharm.2021.121245
  23. Hanson SM, Singh S, Tabet A, Sastry KJ, Barry M, Wang C. Mucoadhesive wafers composed of binary polymer blends for sublingual delivery and preservation of protein vaccines. J Control Release. 2020;330:427–437. Available from: https://doi.org/10.1016/j.jconrel.2020.12.029
  24. Bartkowiak A, Lewandowicz J, Rojewska M, Krüger K, Lulek J, Prochaska K. Study of viscoelastic, sorption and mucoadhesive properties of selected polymer blends for biomedical applications. Journal of Molecular Liquids. 2022;361:119623. Available from: https://doi.org/10.1016/j.molliq.2022.119623
  25. Comoglu T, Ozyilmaz ED. Orally disintegrating tablets and orally disintegrating mini tablets – novel dosage forms for pediatric use. Pharmaceutical Development and Technology. 2019;24(7):902–914. Available from: https://doi.org/10.1080/10837450.2019.1615090
  26. Kamaly N, Yameen B, Wu J, Farokhzad OC. Degradable Controlled-Release Polymers and Polymeric Nanoparticles: Mechanisms of Controlling Drug Release. Chem Rev. 2016;116(4):2602–2663. Available from: https://doi.org/10.1021/acs.chemrev.5b00346
  27. Lim SSB, Schug S, Krishnarajah J. The Pharmacokinetics and Local Tolerability of a Novel Sublingual Formulation of Buprenorphine. Pain Med. 2019;20(1):143–152. Available from: https://doi.org/10.1093/pm/pnx321

Copyright

© 2023 Published by Krupanidhi College of Pharmacy. This is an open-access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/) 

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